ENDOSCOPIC ANTI REFLUX MUCOSAL ABLATION THERAPHY (ARMA) FOR THE TREATMENT OF PROTON PUMP INHIBITOR DEPENDENT GASTRO ESOPHAGEALREFLUX DISEASE: OPEN LABEL SINGLE CENTER OBSERVATIONAL STUDY
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 216
- 试验地点
- 2
- 主要终点
- Improvement in Gastro esophageal reflux disease symptoms by more than 50% from baseline at 3 months
研究概览
简要总结
OBJECTIVES To study the safety and efficacy of Endoscopic Anti Reflux Mucosal Ablation (ARMA) procedure for the treatment of proton pump inhibitor (PPI) dependent gastro-esophageal reflux disease (GERD)
DESIGN OF THE Prospective interventional study Sample size: 216
详细描述
In patients fulfilling inclusion criteria and willing for ARMA, the procedure involves ablation of the mucosa of the EGJ using TT knife (ARMA). Subsequently, saline solution mixed with indigo-carmine is injected at the submucosa level to raise a submucosal bleb, followed by ablation of the mucosa along the lesser curvature using TT knife.The approximate duration of the procedure is 40min.
Submucosal injection and elevation will not be used as a part of ARMA procedure for 10 patients amended protocol version 2.0
Follow up will include objective evaluation of reflux disease with: upper endoscopy, esophageal manometry, pHmetry,reflux questionnaire.
Inclusion criteria
- Patients (between 18 to 60 years of age) with PPI dependent GERD and pathologic esophageal acid exposure as documented by percentage time esophageal PH less than 4 of more than 4.2% on PH-metry during 24-hrs period while off PPI
- Patients who are willing to pay the expenses of the ARMA procedure
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Patients (between 18 to 60 years of age) with PPI dependent GERD and pathologic esophageal acid exposure as documented by percentage time esophageal PH less than 4 of more than 4.2% on PH-metry during 24-hrs period while off PPI
- •Patients who are willing to pay the expenses of the ARMA procedure
排除标准
- •• Large Hiatal hernia >3cm
- •Gr C/D esophagitis
- •Lower esophageal sphincter (LES) pressure<5 or >15 mm Hg
- •Paraesophageal hernia
- •GE flap valve grade IV (Hill's classification)
- •Barretts esophagus
- •Esophageal dysmotility
- •ASA physical status >II
- •Previous esophageal or gastric surgery
- •Pregnancy
结局指标
主要结局
Improvement in Gastro esophageal reflux disease symptoms by more than 50% from baseline at 3 months
时间窗: 3 months
Improvement in Gastroesophageal reflux disease symptoms by more than 50% from baseline at 3 months which would be assessed based on visual analog scale VAS 0 LOW SCORE 10 WORSE SYMPTOM SCORE
次要结局
- Improvement in lower esophageal sphincter pressure at 3 months(12 months)
- Improvement in esophageal acid exposure(6 months)
- requirement of PPI at 3, 6 and 12 months(requirement of PPI at 3, 6 and 12 months)
研究者
Rakesh Kalapala
PRINCIPAL INVESTIGATOR
Asian Institute of Gastroenterology, India